510(k) K163684 ยท GEH Unit, Cryosurgical, Accessories
C2 CryoBalloon Ablation System
| Applicant | C2 Therapeutics, Inc., Redwood, Ca CA, US |
| Decision | Substantially Equivalent, Jan 23, 2018 |
| Received | Dec 28, 2016 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K163684
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Dec 3, 2018 | PENTAX of America Inc C2 CryoBalloon Controller, REF: FG-1017, with Controller Software v1.18.258
The C2 CryoBalloon Ablation System is intended to be used as a cryosurgical tool in the field of general surgery, specifica Terminated |
GEH | None listed |
| Dec 3, 2018 | PENTAX of America Inc Pentax Medical C2 CryoBalloon Standard Focal Catheter, Model FG 1028, Sterile, RX.
Product Usage:
The C2 CryoBalloon Ablation System is intended to be used as a cryosurgical tool in the field of gene Terminated |
GEH | None listed |
| Dec 3, 2018 | PENTAX of America Inc Pentax Medical C2 CryoBalloon Pear Focal Catheter, Model FG 1024, Sterile, RX.
Product Usage:
The C2 CryoBalloon Ablation System is intended to be used as a cryosurgical tool in the field of general Terminated |
GEH | None listed |
| Dec 3, 2018 | PENTAX of America Inc Pentax Medical C2 CryoBalloon Standard 90 degree Catheter, Model FG 1030, Sterile, RX.
Product Usage:
The C2 CryoBalloon Ablation System is intended to be used as a cryosurgical tool in the field of Terminated |
GEH | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.